Clinical Research Associate (French/German Speaking) (Remote)

The Clinical Research Associate is responsible for supporting clinical activities for domestic and international studies as well as support other related initiatives, as required.

Responsibilities:

• Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study.
• Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements.
• Create consent and assent templates specific to the needs of the planned study.
• Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent.
• Train site staff on protocol requirements, source documentation, and case report form completion.
• Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent/assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments.
• Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted.
• Coordinate project meetings.
• Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc.
• Participates in team meetings and tracks action items.
• Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.

Education and Experience:

Minimum Requirements:

• B.S. or B.A. and/or an equivalent combination of education or experience
• CRA certification preferred
• Fluent in English and French or German
• Available to travel on short notice and independently manage travel schedules.
• Direct experience in participating in the execution of clinical research studies.
• Must have analytical skill, be detail oriented and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.

Preferred Skills/Competencies:

• Excellent written and effective verbal communication skills.
• Ability to communicate at all levels of an organization.
• PC skills; word processing, spreadsheet, database, Internet search and utilization.
• Flexible and able to work in a fast-paced environment.
• Team player.
• Ability to organize and judge priorities.
• Excellent ability to generate and maintain accurate records.